Possible Side Effects

What Are Possible Serious Side Effects of XOSPATA?

Posterior reversible encephalopathy syndrome (PRES)

What it is

  • A condition that affects the brain
    • If PRES is suspected, your doctor will do a test to check for it
    • If you develop PRES, your doctor will stop treatment with XOSPATA

Symptoms

  • Seizure
  • Headache
  • Decreased alertness
  • Confusion
  • Reduced eyesight, blurred vision, or other visual problems

Heart rhythm problems (QT prolongation)

What it is

  • Heart problem called QT prolongation
    • More likely to happen in people with low blood magnesium or low blood potassium levels

Symptoms

  • Change in heartbeat (fast or irregular)
  • Feeling dizzy, lightheaded, or faint

Inflammation of the pancreas (pancreatitis)

What it is

  • A condition that affects the pancreas

Symptoms

  • Severe stomach (abdomen) pain that does not go away
  • Pain may happen with or without nausea and vomiting

What Are the Most Common Side Effects of XOSPATA?

  • Joint or muscle pain
  • Changes in liver function tests
  • Fatigue
  • Fever
  • Diarrhea
  • Shortness of breath
  • Swelling due to fluid retention
  • Rash
  • Nausea
  • Mouth sores
  • Pneumonia
  • Cough
  • Infection that has spread through your body (sepsis)
  • Headache
  • Low blood pressure
  • Dizziness
  • Vomiting

Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking XOSPATA if you develop certain side effects during treatment with XOSPATA.

These are not all of the possible side effects of XOSPATA. Call your doctor for medical advice about side effects.

You are encouraged to report side effects to the FDA at 1-800-FDA-1088 or .